NCT01020656

Brief Summary

Purpose: To establish the prevalence of anticoagulant, aspirin, and clopidogrel use in patients undergoing vitreoretinal surgery, and to compare the outcome of peribulbar anesthesia between users and non-users.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
206

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 25, 2009

Completed
Last Updated

November 25, 2009

Status Verified

November 1, 2009

Enrollment Period

5 months

First QC Date

November 24, 2009

Last Update Submit

November 24, 2009

Conditions

Retinal Detachment

Keywords

anticoagulant agentsantiplatelet agentsvitreoretinal surgeryPatients suffered from retinal detachment

Study Arms (7)

group 1

patients with no anticoagulants used as the control group

group 2

patients treated with anticoagulant therapy (warfarin, fluindone, acenocoumarol)

group 3

patients treated with aspirin

group 4

patients treated with clopidogrel therapy

group 5

patients treated with both anticoagulant and aspirin medications

group 6

patients treated with both anticoagulant and clopidogrel medications

group 7

patients treated with both aspirin and clopidogrel medications

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We analyzed the chart of 239 eyes (206 patients) which underwent posterior segment surgery with peribulbar anesthesia.

You may qualify if:

  • Take or no anticoagulant treatment before surgery,
  • Vitreoretinal surgery

You may not qualify if:

  • No surgery
  • Anesthetic complication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ophthalmology Unit CHU Dijon

Dijon, Burgundy, 21000, France

Location

MeSH Terms

Conditions

Retinal Detachment

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 24, 2009

First Posted

November 25, 2009

Study Start

January 1, 2009

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

November 25, 2009

Record last verified: 2009-11

Locations

FR(1)